remote ischemic conditioning in lymphoma patients receiving anthracyclines

Conditions: Anthracycline-induced Cardiac Toxicity; Lymphoma

Summary: multinational, prospective, proof of concept phase ii, double-blinded, sham-controlled, randomized clinical trial (rct) to evaluate the efficacy and safety of remote ischaemic preconditioning (ripc) in lymphoma patients receiving anthracyclines.

multinational, prospective, proof of concept phase ii, double-blinded, sham-controlled, randomized clinical trial (rct) to evaluate the efficacy and safety of remote ischaemic preconditioning (ripc) in lymphoma patients receiving anthracyclines. patients scheduled to undergo ≥5 chemotherapy cycles will be eligible. patients fulfilling all inclusion and no exclusion criteria will be enrolled and undergo baseline cardiac magnetic baseline (cmr), and high sensitivity troponin (hstn) and nt-probnp blood test. patients with confirmed lvef \>40% by cmr will be randomized 1:1 to ripc vs simulated ripc (sham). after the third chemotherapy cycle, a second cmr+ hstn/ nt-probnp will be performed for the validation of the early marker of cardiotoxicity. a third hstn/ nt-probnp blood test will be performed in the last chemotherapy cycle. nine weeks after finishing chemotherapy, a last cmr+ hstn/ nt-probnp will be performed. patients will be followed-up for clinical events at 6, 12, 18, 30 and 42 months until the last patient undergoes the final cmr. when the last patient undergoes the third cmr, the follow-up will be closed. the median follow-up estimation for clinical endpoints is 24 months (range: 6 to 42 months).

Eligibility criteria:
inclusion criteria: ≥18 years old first lymphoma diagnosis scheduled to undergo ≥5 chemotherapy cycles including anthracyclines. pre-chemo lvef \>40% on screening echocardiography. presence of ≥1 of the following risk factors for developing cardiotoxicity: previous coronary artery disease (any of the following): previous coronary revascularisation (pci or cabg) or medical history of previous significant nonrevascularized coronary stenosis previous acute coronary syndrome / acute myocardial infarction with a lvef \> 40 lvef 41-54% age ≥ 65 years old previous diagnosis of arterial hypertension (with or without treatment) chronic kidney disease (estimated glomerular filtration rate \<60ml/min/1.73m2) current or former smoker. obesity (bmi≥30 kg/m2) lvh on screening echocardiography (lv thickness ≥12mm). high alcohol intake (≥21 alcoholic beverages per week) sinus rhythm on screening ecg previous diagnosis of diabetes (except those treated with sulfonylureas or those with neuropathy) previous non-anthracycline-based chemotherapy signed informed consent form (icf) exclusion criteria: * history of any of the following diseases: * any cancer who received anthracyclines treatment before the index episode. * previous clinical diagnosis of heart failure. * permanent atrial fibrillation (af). * severe valvular or sub-valvular heart disease. * severe peripheral arterial disease in the upper extremities or arteriovenous (av) shunt in the arm selected for ripc. * clinical diagnosis of diabetes neuropathy * contraindication for cmr: * severe claustrophobia. * any device which is known to threaten or pose hazard in all mr environments (http://www.mrisafety.com/). * patients with implanted biomedical cardiac devices: pacemakers, icds or crt. * severe thrombocytopenia (platelets \<50,000/µl) on any blood test within the previous 3 months. * patients participating in other clinical trials. * impossibility to consent or undergo study follow-ups.